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临床试验/NCT06169761
NCT06169761招募中不适用

Assessment of Tongue Protrusion Motor Skills in Healthy Adult

Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年12月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Tongue protrusion peak pressure

研究概览

简要总结

This study aims to evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles).

详细描述

The tongue is an organ involved in multiple essential daily functions (such as eating, speaking, and breathing). Normative values exist for the motor skills of tongue elevation in individuals. However, data regarding protrusion are lacking. Yet, the protrusive strength of the tongue is of particular interest. Indeed a weak protrusive tongue strength may contribute to sleep apnea and swallowing disorders. Therefore, this study aims to collect normative and clinimetric (validity and reliability) data of tongue protrusion strength and endurance among healthy adults.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18 years of age or older

排除标准

  • Eating disorder
  • Dysphagia
  • Cardiorespiratory disorder
  • Previous or ongoing obstructive sleep apnea-hypopnea syndrome
  • Neurological conditions (including neuromuscular disorders)
  • Previous or ongoing cancer of the head or neck
  • Pregnancy
  • Any physical or mental condition that may affect the ability to consent

研究组 & 干预措施

Healthy adults

Healthy adults of 18 years and older will fill out the STOP-BANG Questionnaire and undergo protrusive motor skills measurements.

干预措施: Assessment of motor skills of the tongue and others muscles, see below) and risk for sleep apnea (Other)

结局指标

主要结局

Tongue protrusion peak pressure

时间窗: Measured two times: at baseline and after 2 to 4 weeks

Tongue peak pressure during protrusion movements will be measured via the IOPI device

Tongue protrusion endurance

时间窗: Measured two times: at baseline and after 2 to 4 weeks

Tongue endurance during protrusion movements will be measured via a timer (the time in seconds until the participant is not able to sustain tongue protrusion as controlled via the IOPI).

次要结局

  • Tongue elevation peak pressure(Measured two times: at baseline and after 2 to 4 weeks)
  • Maximum Inspiratory and Expiratory Pressure(Measured once at baseline)
  • Tongue elevation endurance(Measured two times: at baseline and after 2 to 4 weeks)
  • Handgrip Strength(Measured once at baseline)
  • Tongue mobility restriction(Measured once at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Poncin

Principal Investigator

Université Catholique de Louvain

研究点 (1)

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